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ID

43577

Description

Study Part: Vital Signs Week 5 PK Visit (Visit 9). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

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Versions (2)
  1. 23/10/17 23/10/17 -
  2. 20/09/21 20/09/21 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

20 settembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Vital Signs Week 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165

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    Vital Signs Week 5 PK Visit (Visit 9)

    1 Formulaires  
    VITAL SIGNS
    Description

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Patient Number
    Description

    Patient Number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Centre Number
    Description

    Centre Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Reading/Set No.
    Description

    Set number

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0150098 (Data Set)
    Date and Time
    Description

    Date and Time

    Type de données

    datetime

    Alias
    UMLS CUI [1]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Semi-supine BP Systolic
    Description

    systolic pressure

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    Semi-supine BP Diastolic
    Description

    diastolic pressure

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    Semi-supine HR
    Description

    Heart rate

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    Time
    Description

    Time

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Standing BP Systolic
    Description

    systolic pressure standing

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Standing BP Diastolic
    Description

    diastolic pressure standing

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Standing HR
    Description

    Heart rate standing

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2029905 (heart rate while standing)
    Retour au début de la page

    Similar models

    Vital Signs Week 5 PK Visit (Visit 9)

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item
    Reading/Set No.
    text
    C0150098 (UMLS CUI [1])
    Set number
    Code List
    Reading/Set No.
    CL Item
    Pre-dose (Pre-dose)
    CL Item
    +4.5 hrs (+4.5 hrs)
    CL Item
    +12.5 hrs (+12.5 hrs)
    CL Item
    +24.5 hrs (+24.5 hrs)
    Date and Time
    Item
    Date and Time
    datetime
    C1264639 (UMLS CUI [1])
    systolic pressure
    Item
    Semi-supine BP Systolic
    text
    C0871470 (UMLS CUI [1])
    diastolic pressure
    Item
    Semi-supine BP Diastolic
    text
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Semi-supine HR
    text
    C0018810 (UMLS CUI [1])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    systolic pressure standing
    Item
    Standing BP Systolic
    text
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    diastolic pressure standing
    Item
    Standing BP Diastolic
    text
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate standing
    Item
    Standing HR
    text
    C2029905 (UMLS CUI [1])
    Retour au début de la page 

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